Nipocalimab Dose Selection in Generalized Myasthenia Gravis.

ABSTRACT: Nipocalimab is a fully human immunoglobulin G (IgG)1 monoclonal antibody (mAb) designed to selectively block the IgG binding site of neonatal fragment crystallizable receptor (FcRn) to inhibit IgG recycling and decrease circulating IgG, including pathogenic IgG autoantibodies (such as antiacetylcholine receptor, anti-muscle-specific kinase, and anti-low-density lipoprotein-related protein 4 antibodies in generalized myasthenia gravis [gMG]). A mechanistic model, integrating serum nipocalimab concentrations, FcRn occupancy, and total serum IgG data from five phase 1 studies in healthy adult participants and one phase 2 (Vivacity-MG) study in adult participants with gMG, was developed. The relationship between total serum IgG reduction and placebo-corrected MG-Activities of Daily Living scor

SUBMITTER: Valenzuela B 

PROVIDER: S-EPMC12706425 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature